A SYSTEM FOR MEASURING PELVIC MUSCLE STRENGTH IN WOMEN

Bio Logic Engineering, Inc., Dexter MI

Investigators

Abstract

When stress urinary incontinence begins at a young age, often after giving vaginal birth, it initiates a lifelong problem. The cumulative incidence of urinary incontinence increases with age, affecting up to 38% of women over the age of 65 years. Assessment of pelvic muscle strength is a common clinical test for these patients. However, measurements of pelvic muscle strength are presently either subjective or contain artifact, commonly due to the non-isometric nature of the measurements. During Phase I of this research project a new system will be developed for directly measuring maximum voluntary isometric strength and contractile properties of the female pelvic floor muscles during hard coughs and valsalva provocation tests. The centerpiece of the system is a novel intravaginal transducer, the subject of a recent invention disclosure. The system will be refined using a microcomputer, then miniaturized with embedded microcontrollers. Feasibility tests will be conducted on 30 women. The device has utility for gynecologists, nurse-clinicians and physical therapists in assessing pelvic floor function, evaluating the efficacy of exercise interventions, and as a biofeedback device for training proper technique. Exhaustive clinical assessment and optimization of prototype system performance will be conducted in Phase II. PROPOSED COMMERCIAL APPLICATIONS: Our goal is to provide a low-cost, easy-to-use product that will safely and accurately measure pelvic floor muscle strength in adult women. The design will enable in-clinic testing by physicians, nurse- practitioners and physical therapists. Its portability will enable in-home use for gynecological assessments and multi-week exercise interventions as a biofeedback training device. The market for the device is widespread with use in secondary and tertiary care hospitals, general obstetric and gynecological clinics, academic research laboratories, and outpatient clinics run by nurse clinicians, nurses and physical therapists. We anticipate sales volume to be many tens of thousands of units at an estimated retail cost of approximately 5,000 each.